Various drugs have been developed over the years to aid an individual to recover from various illnesses and medical conditions. These medications are either administered by health care professionals or are self-administered by the patient according to the directions of a health care professional. Probably the most common medicinal drugs are those used to aid in pain management and take the form of individual tablets of mild analgesics such as ‘low dose aspirin’ to opioids administered by infusion pumps. The majority of these pain control medications are self-administered by the patient according to directions from the responsible health care professional treating the patient, especially when administered in the form of one or more tablets at designated time intervals.
For patients who have undergone major surgery, who are in end-stage cancer or experiencing other conditions where there is acute pain, the use of opioids or other high strength medications are needed to adequately manage the patient's pain. These medications can be administered by intramuscular injection. However, such administration typically requires a medical professional to accomplish the administration of the analgesic. The concept of a patient controlled analgesic demand system and self administration of opioids was first suggested in the early 1970's. The first commercially available infusion pump was developed in 1976, however, its use was limited to adults.
Patient Controlled Analgesia (PCA) is considered one of the most effective analgesic methods for relieving acute pain. The technique allows the administration of on-demand analgesics using an infusion pump that delivers controlled doses of pain medications when the patient presses a button. Different types of analgesics can be delivered using a PCA pump through variable routes of administration: Intravenous, intrathecal epidural perineural and transdermal, among others. PCA is now regularly used for adult patients to manage acute pain. Advantages of the use of PCA include the lack of waiting time for patients requiring pain medication before a caregiver can increase the dosage of medication. In this way, the patient spends less time in pain and as a corollary to this, patients tend to use less medication than in cases in which medication is given according to a set schedule.
Studies of PCA for use in treating children were begun in the 1980's, and is now considered an efficient and well tolerated technique for the management of acute postoperative pain in children. PCA is also useful in other areas of pediatric care such as pediatric oncology, burns, palliative care and acute painful conditions such as vaso-occlusive crisis of sickle cell anemia. PCA is a safe technique that allows a sustained analgesic level in the blood with the possibility of self administration of boluses if the pain increases.
Other benefits of PCA for children include increased patient and parent satisfaction compared to intramuscular injections of analgesics, since children are more likely to tolerate pain that to have another injection. Additional benefits realized by children using PCA include the opportunity to better estimate the pain occurring after physiotherapy, pain relief during mobilization or dressing changes and an improved sense of control over their illness. The safety and efficacy of PCA in children has been established and can be considered as a standard for the treatment of acute painful conditions for pediatric patients.
However, the primary contraindication for the use of PCA in the pediatric population is the inability of pediatric patients to understand the concept of PCA or how to activate the device. This contraindication requires that patients should be carefully screened to guarantee adequate patient selection. While age along should not be considered as a criteria for inclusion or exclusion, children who are five years of age or older are more likely to benefit from PCA. For the appropriate universe of selected pediatric patients, they, their parents, and their care givers must be provided with education regarding what to expect from PCA. For example, it should be explained that PCA helps controlling the pain rather than eliminating it and that the child must be the only one who activates the delivery of the analgesic.
Therefore, a device and associated system to help children understand and self-administer analgesic medication is needed.